LCP 240.046Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982164636), received between Jun 26, 2017 and Apr 1, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE TESTING PERIARTICULAR AIMING ARM FOR PROXIMAL TIBIA PLATE, THE 14 HOLE RIGHT PLATE DID NOT MATCH UP CORRECTLY. IT IS POSSIBLE THAT THE PLATE WAS BENT PREVIOUSLY SINCE IT DID NOT MATCH UP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5MM LCP PROXIMAL TIBIA PLATE 14 HOLES/262MM-RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978084 ↗
• InjuryDec 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. DURING PROCEDURE, THE PLATES HAD TO BE CUT AWAY TO REMOVE THE SCREWS. ALL IMPLANTS WERE REMOVED SUCCESSFULLY. HOWEVER, THERE WAS DIFFICULTY REMOVING THE FRAGMENTS THAT WERE GENERATED FROM THE BROKEN DEVICES AND TREPHINE WAS USED TO REMOVE THE SCREW HEAD. NO OTHER DEVICE WAS USE BEFORE USING THE TREPHINE. ORIGINAL IMPLANTATION WAS ON (B)(6) 2015, FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS REPORT ADDRESSES THE INTRA-OP EVENT OF THE DIFFICULTY REMOVING THE SCREW, WHILE (B)(4) WILL CAPTURE POST OP EVENT THAT INVOLVES THE INFECTION/ONE BROKEN SCREW. THIS REPORT IS FOR ONE (1) 4.5MM LCP PROXIMAL TIBIA PLATE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8201970 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF ONE (1) UNKNOWN 3.5 MM LOCKING SCREW THAT WAS BROKEN AND ONE (1) UNKNOWN 5MM CANNULATED LOCKING SCREW THAT WAS COLD WELDED TO 4.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE 12 HOLES/226MM LEFT DUE TO INFECTION. THE PLATE HAD TO BE CUT AWAY TO REMOVE THE SCREW. ALL IMPLANTS INCLUDING THREE (3) UNKNOWN 5.0 MM CANNULATED SCREWS, SIX (6) UNKNOWN LOCKING SCREWS, FOUR (4) UNKNOWN CORTEX SCREWS, (1) UNKNOWN LOCKING SCREW, AND ONE (1) UNKNOWN CANNULATED SCREW WERE REMOVED SUCCESSFULLY. THERE WAS DIFFICULTY REMOVING THE FRAGMENTS THAT WERE GENERATED FROM THE BROKEN DEVICE AND TREPHINE WAS USED TO REMOVE THE SCREW HEAD. ORIGINAL IMPLANTATION WAS ON (B)(6) 2015, FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT CAPTURES THE POST-OPERATIVE INFECTION AND BROKEN SCREWS. THE INTRA-OPERATIVE EVENT INVOLVING THE PLATE BEING CUT AWAY IS CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A PROXIMAL TIBIA PLATE-RIGHT. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8196813 ↗
• InjuryJun 26, 2017Break; Break

  IT WAS UNABLE TO BE CONFIRMED IF CULTURES WERE TAKEN OR WHAT THE RESULTS OF THE CULTURES WERE.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 6668004 ↗